Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers

Pilot Study for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye in Contact Lens Wearers

The pilot study objective is to evaluate the potential benefits of LipiFlow® System treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing for improvement in meibomian gland function and reduction of dry eye symptoms in comparison to an untreated control.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Intervention / Treatment: Device: LipiFlow treatment

Detailed Description

This is a prospective, non-significant risk, open-label, randomized clinical trial of LipiFlow® treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye. All subjects undergo examination to determine study eligibility and to capture the Baseline status. Subjects are randomized to receive LipiFlow® treatment (Treatment Group) or no LipiFlow® treatment (Untreated Control Group). The Treatment group is evaluated one month after receiving LipiFlow® treatment. Study endpoints are evaluated at 3 Months by comparing the Treatment Group to the Untreated Group. To facilitate subject recruitment, the Untreated Control group receives Crossover LipiFlow® treatment (Crossover Treatment Group) at 3 Months. The Crossover Treatment group is evaluated one month after receiving LipiFlow® treatment (4 Months visit).

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • School of Optometry, The University of Alabama at Birmingham
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose and Throat Associates, P.A.
  • Pennsylvania
    • Hanover, Pennsylvania, United States, 17331
      • May Eye Care Center & Associates
  • Washington
    • Kirkland, Washington, United States, 98034
      • Specialty Eyecare Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of meibomian gland dysfunction and dry eye
• At least 18 years of age
• Willing to comply with randomization, attend all study visits and follow patient instructions
• Habitual soft contact lens wearer 2 to 18 hours/day and 4 to 7 days/week
• No change in contact lens type or dimensions for the past 3 months
• Clinician assessment of acceptable contact lens fit and disinfecting solution
• Tear film interferometry of 100 units or less

Exclusion Criteria:

• Systemic disease conditions that cause dry eye
• Use of systemic medications known to cause dryness
• History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
• Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
• Use of other treatments for meibomian gland dysfunction or dry eye except over the counter lubricants or dietary supplements
• Participation in another ophthalmic drug or device trial in the past month
• Employee, relative of employee or associate of the clinical site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LipiFlow; Single 12-minute LipiFlow treatment	Device: LipiFlow treatment; The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.; Other Names: LipiFlow® Thermal Pulsation System
NO_INTERVENTION: Untreated Control; Untreated Control (No Intervention)
EXPERIMENTAL: Crossover LipiFlow Treatment; Crossover LipiFlow treatment of the untreated control group after 3 months	Device: LipiFlow treatment; The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.; Other Names: LipiFlow® Thermal Pulsation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Meibomian Gland Score From Baseline at 3 Months	The Primary Endpoint was intended to assess for improvement in meibomian gland function in symptomatic contact lens wearers after LipiFlow treatment in comparison to an untreated control.The Primary Endpoint was defined as the mean change in meibomian gland score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months	The Secondary Endpoint was intended to assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The Secondary Endpoint was defined as the mean change in SPEED score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.	3 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months	Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). A pre-specified exploratory analysis was to compare the mean change in comfortable contact lens wear time between Baseline and 3 Months for the LipiFlow group vs. untreated control.	3 Months
Mean Change in Meibomian Gland Score From Baseline at 1 Month	The mean change in meibomian gland score from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving crossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.	1 Month
Mean Change in Dry Eye Questionnaire From Baseline at 1 Month	The mean change in dry eye symptoms from Baseline based on the SPEED questionnaire score was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.	1 Month
Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month	Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). The mean change in comfortable contact lens wear time from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month.	1 Month

Collaborators and Investigators

• Sponsor: TearScience, Inc.
• Investigators: Study Director: Christy Coleman, OD, MPH, TearScience, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: March 30, 2014
• First Submitted That Met QC Criteria: April 2, 2014
• First Posted (ESTIMATE): April 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2017
• Last Update Submitted That Met QC Criteria: September 16, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: LF006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED